UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050770 |
|---|---|
| Receipt number | R000057851 |
| Scientific Title | Treatment and loss of independence/progression of nursing care levels in older lymphoma patients |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/04/05 12:27:39 |
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Basic information
Public title
Integration of cancer therapy and long-term care in older patients
Acronym
Lymphoma and loss of independence in the elderly, LyLIE study
Scientific Title
Treatment and loss of independence/progression of nursing care levels in older lymphoma patients
Scientific Title:Acronym
Lymphoma and loss of independence in the elderly, LyLIE study
Region
| Japan |
Condition
Condition
malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of developing loss of independence and progression of nursing care levels in older patients with non-Hodgkin lymphoma which can potentially be cured by anti-neoplastic agents alone and to analyze its risk factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
loss of independence and progression of nursing care levels
Key secondary outcomes
risk factors for loss of independence and progression of nursing care levels
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
lymphoma patients older than seventy years of age
Key exclusion criteria
patients who cannot do decision-making due to significant cognitive impairment
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | terui |
| Middle name | |
| Last name | yasuhito |
Organization
Saitama Medical University Hospital
Division name
department of hematology
Zip code
350-0495
Address
38 Morohongou Moro-cho Iruma-gun, Saitama prefecture
TEL
049-276-1111
yasuhito@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tamura |
| Middle name | |
| Last name | Kazuo |
Organization
NPO Clinical Hematology/Oncology Treatment Study Group
Division name
study office
Zip code
819-0030
Address
1-14-6 Muromigaoka, Nishi-ku, Fukuoka City
TEL
092-406-4166
Homepage URL
ktamura@fukuoka-u.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital
Address
38 Morohongou Moro-cho Iruma-gun, Saitama prefecture
Tel
049-276-1111
yasuhito@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Older lymphoma patients are to be followed for investigating loss of independence or aggravation of nursing care levels at 6 month, 1 year and 2 years after they are registered or started treatment for the underlying disease. They also have G8 and Kihon Check List studied at the same times and risk factors of loss of independence and aggravation of nursing levels are analyzed.
Management information
Registered date
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057851
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
